Eli Lilly and Co. is betting that the Centers for Medicare & Medicaid Services will lift Medicare coverage limits on a new class of amyloid-busting drugs that treat early Alzheimer’s disease. The agency’s stance may be influenced by the expected release of new clinical trial data on the company’s experimental drug donanemab and that of a rival, Eisai’s recently approved lecanemab (Leqembi), a company executive told Reuters Friday.
The new evidence from Lilly, to be unveiled in June, will show that donanemab’s ability to help clear amyloid plaques from the brain can help patients, Derek Asay, Lilly’s senior VP-government strategy and federal accounts told the news outlet.
The key to this potential coverage turnaround is also connected to the drug’s approval pathway. Unlike its competitors and predecessors, greenlit by the Food and Drug Administration under an accelerated pathway, Lilly’s drug is up for traditional approval.
“We believe that they (Medicare) will provide what we would call outright coverage like they do for every other FDA-approved medication,” Asay said.
The recently approved rival lecanemab (Leqembi), and Leqembi’s controversial forerunner aducanumab (Adulhelm), are covered for clinical trial use only. CMS has said coverage will remain strictly limited for the entire drug class, in part due to the drugs’ risk-benefit profile and the need for more safety and efficacy evidence. The drugs, disease-modifying monoclonal antibodies, target Alzheimer’s brain plaques, a hallmark feature of the disease. They are also associated with a risk for brain bleeds.
Patient advocates have decried CMS’s current coverage decision, and the agency has said it is open to reconsidering the coverage decision when new evidence of clinical benefit becomes available, or when a drug in the class receives traditional FDA approval based on clinical benefit.
In data released in 2021, participants taking donanemab for more than a year showed a 32% slower decline in thinking and daily function measures when compared with a placebo group. Lilly’s bid for accelerated approval was rejected by the FDA in January, leaving the company with the option of applying for traditional approval when it had more clinical trial evidence to share.